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Model Based Fast Anatomical Mapping (MFAM)

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ClinicalTrials.gov Identifier: NCT03349476
Recruitment Status : Enrolling by invitation
First Posted : November 21, 2017
Last Update Posted : October 7, 2021
Sponsor:
Collaborator:
Biosense Webster, Inc.
Information provided by (Responsible Party):
Vivek Reddy, Icahn School of Medicine at Mount Sinai

Brief Summary:
This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.

Condition or disease Intervention/treatment Phase
Paroxysmal Atrial Fibrillation Persistent Atrial Fibrillation Device: MFAM Not Applicable

Detailed Description:

This prospective, multicenter observational study will examine the ability of model based fast anatomical mapping (mFAM) to create left atrial (LA) geometry for atrial fibrillation ablation.

Specifically, the study will assess the following issues in atrial fibrillation ablation:

  1. Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)
  2. Left atrial geometry creation time
  3. Fluoroscopy time

The clinical team will hypothesize that this approach will lead to accurate LA geometry creation more rapidly and using less fluoroscopy than standard techniques

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Left Atrial Anatomy Reconstruction Using Model Based Fast Anatomical Mapping
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MFAM

The mFAM Workstation is a computerized system used to reconstruct the shape of the left atrium of the heart, by fitting a parametric shape model to points data acquired by a catheter.

The mFAM Workstation uses recorded catheter positions and other data inputs collected from various types of multi-electrode catheters and generates output data files that can be displayed as a 3D anatomic structure.

Device: MFAM

Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure.

mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy





Primary Outcome Measures :
  1. Accuracy of map [ Time Frame: hospital discharge, average 24 hours post procedure ]
    Accuracy of map (defined as the distance between the ablation points and the surface of the mFAM geometry)


Secondary Outcome Measures :
  1. Left atrial geometry creation time [ Time Frame: hospital discharge, average 24 hours post procedure ]
    The amount of time it takes to create the geometrical map using Carto and MFAM during the ablation procedure

  2. Fluoroscopy amount [ Time Frame: hospital discharge, average 24 hours post procedure ]
    The amount of Fluoroscopy (radiation) used during the ablation procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Have AF as follows:

    1. Paroxysmal AF - defined as AF that is non-sustained (terminate without electrical or pharmacologic cardioversion) lasting < 7 days.
    2. Persistent AF - defined as AF that is sustained > 7 days. Episodes of AF which are terminated by electrical or pharmacologic cardioversion after ≥ 48 hours of AF, but prior to 7 days, should also be classified as persistent AF episodes.
  • Are planned to undergo a first catheter ablation procedure (prior typical atrial flutter is allowed)
  • Have the ability to understand the requirements of the study and sign the informed consent form.
  • Are willing to adhere to study restrictions and comply with all post-procedural follow-up requirements

Exclusion Criteria:

  • Rheumatic heart disease,
  • Current intra-cardiac thrombus
  • Class IV HF
  • Unable to sign consent
  • Unstable angina
  • Recent cerebral ischemic events
  • Contradiction to anticoagulation
  • Prior cardiac surgery
  • Complex congenital heart disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03349476


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Vivek Reddy
Biosense Webster, Inc.
Investigators
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Principal Investigator: Mohit Turagam, MD Icahn School of Medicine at Mount Sinai
Study Chair: Vivek Reddy, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Vivek Reddy, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03349476    
Other Study ID Numbers: 17-02-329
First Posted: November 21, 2017    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Vivek Reddy, Icahn School of Medicine at Mount Sinai:
Atrial Fibrillation
AFIB
Ablation
Paroxysmal
Persistent
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes